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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2019 Physical Medicine 16-229 Complete RESNA ANSI WC-4:2017 Section 20 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles
06/07/2021 Orthopedic 11-383 Complete ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
07/15/2019 General II (ES/
EMC)		 19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
06/07/2021 Orthopedic 11-376 Complete ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
06/27/2016 Materials 8-429 Complete ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
08/21/2017 Cardiovascular 3-149 Complete ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
07/15/2019 Materials 8-513 Complete ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
12/21/2020 Ophthalmic 10-121 Complete ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
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